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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00478-33 | Other Identifier | 2021-A00478-33 |
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| Name | Class |
|---|---|
| Centre de Recherche en Odontologie Clinique UR4847 | UNKNOWN |
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This project aims at studying the evolution of masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) during oral rehabilitation, in children with different types of oral health impairment.
Secondary objectives are to study the relationships between children masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) and its evolution during oral rehabilitation, and:
During examination the following parameters are collected:
Examination and differents tests are performed every six months for a total of 5 years (per participant)
The dental care procedures performed during the study were carried out in the usual way.
This project aims at studying the masticatory parameters and their evolution in children receiving oral rehabilitation at the special care unit (Odontology Department, CHU Estaing, Clermont-Ferrand), for different types of oral health alterations. These data could be used to support the validity of procedural guidelines in the field of functional rehabilitation in pediatric dentistry. The impact of the type of oral alteration on mastication, and the influence of the masticatory function on the quality of life, the eating habits and the height and weight status of children will also be analyzed.
The main objective is to study the evolution of masticatory function (food bolus granulometry, behavior, muscle activity and performance) during a rehabilitation program, in children with different types of oral health impairment.
Secondary objectives are to study the relationships between children masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) and its evolution during oral rehabilitation, and:
This is a follow-up study using criteria from clinical orofacial examination, questionnaires, video recordings of natural food chewing sequences and analysis of food bolus.
Indeed, objective and non-invasive indicators of oro-facial functions and mastication are recorded as part of the usual follow-up of children (according to the recommendations of the American Association of Pediatric Dentistry 2020) during observations (live or on video recordings outside the presence of the family) or interviews with the child and his/her parents (questionnaires), or following masticatory tests.
During children examination, and after questionnaires are completed with the parents or the child himself, these data are collected:
The following parameters are collected from chewing tests:
The dental care procedures performed during the study were carried out in the usual way.
Examination and differents tests are performed every six months for a total of 5 years (per participant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children with ECC | Experimental | Children under 6 with early childhood caries receiving comprehensive dental treatment under general anesthesia |
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| Children with orofacial dysmorphologies/malocclusion | Experimental | Children with orofacial dysmorphologies/malocclusion associated or not with a general condition and in need of a functional or orthodontic treatment |
|
| Children with dental abnormalities | Experimental | Children with dental abnormalities associated or not with a general condition and in need of conservative, orthodontic or prosthetic treatment |
|
| children with healthy oral state | Experimental | children with healthy oral state in the course of their annual follow-up visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental treatment for global oral rehabilitation | Procedure | dental treatment can include conservative, orthodontic, prosthetic or surgical procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 6 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 12 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 18 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 24 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 36 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. | at 48 months |
| Particle size analysis of ready to swallow natural food bolus | Particle size analysis (D50) of ready to swallow natural food boluses of carrot, cheese, or cereals. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between mastication capability, and the type of oral health alteration | Mastication capability is evaluated by particle size analysis (D50). The type of oral health alterations are defined by
| every 6 months for 1year, and then each year for 4 years |
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Inclusion Criteria:
This may include:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Valérie Collado | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU clermont-ferrand | Recruiting | Clermont-Ferrand | France |
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| oral health check up | Other | regular preventive follow-up visit (every 6 months) |
|
| at 60 months |
| Correlation between mastication behavior and the type of oral health alteration | Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T) The type of oral health alterations are defined by
| every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication performance and the type of oral health alteration | Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation) The type of oral health alterations are defined by
| every 6 months for 1year, and then each year for 4 years |
| Correlation between muscle activity and the type of oral health alteration | Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness. The type of oral health alterations are defined by
| every 6 months for 1year, and then each year for 4 years |
| Correlation between mastiaction capability and quality of life | The quality of life will be assessed using questionnaires:
Mastication capability is evaluated by particle size analysis (D50). | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication behavior and quality of life | The quality of life will be assessed using questionnaires:
Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T) | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication muscular activity and quality of life | The quality of life will be assessed using questionnaires:
Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness. | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication performance and quality of life | The quality of life will be assessed using questionnaires:
Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation) | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication capability and eating habits | Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS) Mastication capability is evaluated by particle size analysis (D50). | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication behavior and eating habits | Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS) Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T) | every 6 months for 1year, and then each year for 4 years |
| Correlation between muscular activity and eating habits | Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS) Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness. | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication performance and eating habits | Eating habits are measured by measuring the number of food refusals and texture adaptation at home according to the 7 categories of food (PNNS) Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation) | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication behavior and height and weight status | Mastication behavior is measured by measuring the number of food refusals during mastication tests, measuring the kinematic parameters (number of cycle (nc), mastication time (T) to calculate the masticatory frequency (nc/T) Height and weight status is evaluated by calculating the BMI (body mass index) of children | every 6 months for 1year, and then each year for 4 years |
| Correlation between muscular activity and height and weight status | Muscle activity will be evaluated by measuring the electromyographic activity of masseter and temporal muscles during mastication of gelatines of various hardness. Height and weight status is evaluated by calculating the BMI (body mass index) of children | every 6 months for 1year, and then each year for 4 years |
| Correlation between mastication performance and height and weight status | Mastication performance is evaluated by measuring the heterogeneity of the color of a bicolor chewing gum masticated during a given number of cycles (chewgum test) (Hue standard deviation) Height and weight status is evaluated by calculating the BMI (body mass index) of children | every 6 months for 1year, and then each year for 4 years |
| ID | Term |
|---|---|
| D003729 | Dental Care |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D003752 | Dental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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